I move: "That the Bill be now read a Second Time."
The Health (Miscellaneous Provisions) Bill will amend the Health Act, 1970, the Tobacco (Health Promotion and Protection) Act, 1988, and the Health (Nursing Homes Act), 1990. This composite Bill sets out the Government's proposals: to improve and update the statutory basis for the supply of drugs, medicines and medical and surgical appliances under the general medical services and community drugs schemes; to raise the age at which tobacco products can be sold to young persons from the present age of sixteen years to eighteen years and to raise the maximum fine on persons convicted for selling tobacco products to under age persons from £500 to £1,500; and to empower the Minister for Health and Children to prescribe any necessary administrative and technical details to facilitate the efficient administration of the scheme for the payment of subvention in respect of patients in nursing homes, and also to empower the Minister to make regulations governing standards in private convalescent homes under the Health (Nursing Homes) Act, 1990. As this is a composite Bill with three distinct elements, I propose to speak about each of these elements in turn and then to outline the contents of the Bill as a whole.
Section 59 of the Health Act, 1970, is the statutory basis for the supply of drugs, medicines and medical and surgical appliances under the general medical services and the community drugs schemes, the schemes which allow the reimbursement by the State of medicines taken by patients in the community. It is generally accepted – this point came through in the debate on the Bill in the Seanad – that the original legislation was very good. However, this legislation is 30 years old and we are now dealing with increasingly complex pharmaceutical issues in this millennium which could not have been foreseen when the Health Act, 1970, was drafted.
The Minister's purpose in amending section 59 of the Health Act, 1970, is threefold. The proposals before the House in this Bill are made with a view to: improving and updating the regulation of the supply of drugs, medicines and medical and surgical appliances under the general medical services and community drugs schemes; promoting an equitable and more accountable service in this regard; and better providing for the delivery of community pharmacy services.
Under present arrangements, drugs, medicines and medical and surgical appliances are supplied without charge to persons with full eligibility, that is, medical card holders, under the general medical services scheme in line with criteria for reimbursement. Generally speaking, these items are provided through community pharmacies.
In rural areas, where a general practitioner has a centre of practice three miles or more from the nearest community pharmacy, the doctor dispenses for those patients served from that centre who opt to have their medicines dispensed by him or her. In these circumstances, the general practitioner is known as a "dispensing doctor".
The position in regard to the provision of drugs, medicines and medical and surgical appliances for persons with limited eligibility – non-medical card holders – is that community drugs schemes have been in operation over the years whereby the State meets a proportion of the cost of prescribed products. Under the current scheme, the drug payment scheme, an individual or family pays the first £42 in respect of expenditure on approved prescribed drugs, medicines and medical and surgical appliances and the balance of the cost is met by the State. I stress that a fundamental aspect of a scheme such as the drug payment scheme is that it is not means tested and is open to everyone.
A third arrangement, known as the long-term illness scheme, is in place for persons suffering from a prescribed disease or disability of a permanent or long-term nature whereby drugs are made available without charge in respect of the treatment of the primary condition.
The provisions of the Bill will continue present arrangements. Drugs continue to be supplied without charge to persons with full eligibility. Expenditure incurred by persons with limited eligibility in respect of themselves or their spouse or a dependent member of their family will continue to be recouped in part. In this regard, a dependent member of the family is defined as a child under the age of 18 years or under 23 years, if in full-time education, or a child of any age with a mental or physical disability to the extent that it is not reasonably possible for the child to maintain himself or herself fully and who is living at home. The Bill also continues to provide for the long-term illness scheme.
The Minister's concerns, which I share, are to ensure that arrangements for the supply of drugs, medicines and medical and surgical appliances in the community are equitable, that all arrangements meet accountability requirements and that the service to patients is a quality service.
Section 59 of the Health Act, 1970, as it stands, does not facilitate a clear and transparent approach to reimbursement, does not explicitly provide for accountability and is not adequately structured to promote a quality driven community pharmacy service. Expectations in this regard have changed since 1970 and steps must therefore be taken to bring the legislation into line with current demands and requirements.
The Bill provides for making regulations concerning the granting of approval of drugs, medicines and medical and surgical appliances for reimbursement purposes and the withdrawal of this approval for stated reasons. This will ensure an equitable, transparent and coherent approach to reimbursement. The Minister is also concerned to ensure that there is appropriate flexibility in how the State responds to the potential pharmaceutical needs of a patient. In some cases, it may not be appropriate to make a product universally reimbursable. For example, an over the counter product with a very wide application may be used by the general public in circumstances that do not warrant the use of the product from a clinical point of view – in other words, its use may not be necessary. If such a product is universally reimbursable, a consequent waste of taxpayers' money is inevitable. However, that same product may be of therapeutic necessity for patients with particular conditions and it is important to provide the flexibility to reimburse such products in these circumstances.
As I mentioned earlier, section 59 of the Health Act, 1970, is concerned with the supply of drugs, medicines and medical and surgical appliances in the community. The Bill, therefore, provides for the supply of reimbursable products through community pharmacies as the most appropriate dispensing arrangement in most instances for medicines taken in the community. This reflects current practice and policy in the provision of community pharmaceutical care in line with the contractor agreement for the provision of community pharmacy services under the Health Act, 1970, which was introduced in 1996 and which is pro-active in promoting a quality driven service to the patient.
I have no doubt the service to patients has been enhanced as a result of the new contractor agreement which imposes obligations not in place before. A central and innovative element of the contractor agreement is a clause providing for a review by the pharmacist of the medicine therapy of the patient, including screening for any potential drug therapy problems, therapeutic duplication, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug allergy interactions and clinical abuse or misuse. The review also includes an examination of the rational and cost effective use of the medicine prescribed, including the choice of medicines and the potential for wastage. In addition, the contractor agreement is designed to improve the quality of services by encouraging greater investment in the pharmacy and facilitating the involvement of a greater number of pharmacists in a given pharmacy.
In this context, the Bill makes specific provision for the making of regulations, designed to foster the best possible community pharmacy service in regard to agreements between the proprietor of a community pharmacy and a health board pursuant to which community pharmacies supply drugs and medicines and medical and surgical appliances under the general medical services and community drugs schemes.
However, in terms of supply and value for money – and, in some cases, patient convenience – it is recognised that community pharmacies may not be the most appropriate source of some non drug items and that expertise in this area may lie elsewhere. On this basis, the Bill will also allow the reimbursement of some non drug items supplied through other outlets approved by the Minister in accordance with regulations. The Bill also takes account of the fact that some medical card patients in remote areas will rely on their general practitioners, dispensing doctors, for the supply of medicines.
The general medical services and community drugs schemes are fundamentally concerned with medicines prescribed, dispensed and taken in the community under the supervision of a general practitioner. However, the provisions of the Bill acknowledge the dramatic pharmaceutical advancements of recent years which are likely to continue, perhaps at an even faster pace. In some circumstances, while the patient remains in the community, it may be appropriate for patient safety and monitoring purposes for certain sophisticated drugs to be dispensed in a hospital or clinic setting on an out patient basis. The Bill, therefore, provides for the reimbursement of products provided by an institution that provides a specialist service under the direct supervision of a medical consultant, where approved by the Minister in accordance with regulations.
From the point of view of value for money and accountability, the Bill will empower the Minister to make regulations to provide for the manner in which payments to community pharmacists and others who supply items under section 59 of the Health Act, 1970, are made by the relevant State agencies with responsibility in this matter and for the furnishing of information on items supplied, services provided and the costs involved. Regulations may also be made for the furnishing of information that the relevant State agencies may require by suppliers of drugs, medicines and medical and surgical appliances to those dispensing these products. The Bill, therefore, provides a good legislative basis for verification of claims on the State by those supplying products reimbursable by the State.
I will return to the amendment of section 59 of the Health Act, 1970, when outlining the contents of the Bill but will move on now to the amendment of the Tobacco (Health Promotion and Protection) Act, 1988. The Minister and I regard the battle against smoking as one of the most important public health challenges facing us in the new millennium and this area is one of the Minister's main priorities as Minister for Health and Children. The adverse impact of tobacco consumption on public health is enormous. Tobacco related illnesses kill half of those who use tobacco. Tobacco is a significant burden to individuals, families and society through death, illness and medical costs. It is estimated that smoking related illnesses account for about 7,000 deaths each year in Ireland. There are a number of diseases such as lung cancer, emphysema and heart disease associated with tobacco consumption. Within the European Union, the tobacco epidemic is killing more than half a million citizens each year.
There is particular cause for concern over the reported increase in the level of smoking among children and teenagers. One of the most disturbing facts about smoking is that for the majority of smokers the addiction begins in their childhood or teenage years. In this context, the Minister launched a new multi-media anti-smoking advertising campaign for young females on 10 October as part of our new Ireland Needs a Change of Heart Initiative. The sale of tobacco products to children and underage persons in particular is a most reprehensible practice and is one that has to be tackled aggressively. The report Towards a Tobacco Free Society launched by the Minister on 7 March this year recommends, among other things, raising the age limit at which tobacco products can be sold to young persons to 18 years, as does the report of the Joint Committee on Health and Children on Smoking and Health published in November 1999.
The proposed amendment to the Tobacco (Health Promotion and Protection) Act, 1988 before the House today will have the effect of raising the age at which tobacco products can be sold to young persons from 16 to 18 years and will raise the maximum fine on persons convicted for selling to underage persons from £500 to £1,500. The increase in the maximum fine to £1,500 is the highest amount that can be included in this type of amendment and will act as a further deterrent to retailers. Work is under way in my Department to prepare a new comprehensive tobacco Bill which will take on board many of the other proposals recommended in the report Towards a Tobacco Free Society.
Tobacco advertising plays an important role in promoting tobacco products particularly in relation to young people. A complete ban on all forms of advertising and sponsorship of tobacco products is necessary if we are to reduce children's exposure to inducements to tobacco products. The House will be aware that the Minister advised the tobacco industry here that no further advertising or sponsorship, other than limited retail and trade advertising, would be allowed after 1 July 2000. With regard to an overspill of UK newspapers, magazines and other foreign publications here, new regulations were introduced on 11 July last to prohibit or restrict the importation for sale of newspapers, magazines or publications containing tobacco advertising. My concerns in this area are the promotion and protection of public health and children and the elimination of childhood addiction to tobacco. I have no apologies to make to anyone for introducing the ban on tobacco advertising and sponsorship.
Ireland has for many years been a leading advocate for world-wide control and ultimate elimination of tobacco use from society. We were one of the first countries to introduce restrictions on tobacco advertising and sponsorship by the industry. These measures were later adapted for the whole of the European Union and are now the gold standard internationally. We are also one of the first countries to recognise the impact of environmental tobacco smoke and to introduce prohibitions on smoking in public places. This is a proud tradition of world leadership and we are determined that Ireland will continue in this role.
I now turn to section 3 of the Bill which amends the Health (Nursing Homes) Act, 1990. The Health (Nursing Homes) Act, 1990, which came into effect on 1 September 1993, has two principal objectives. The first is to ensure high standards of accommodation and care in all nursing homes registered under the Act. The second is to provide a system of subventions for dependent persons in need of nursing home care.
With regard to subventions, section 7(2) of the Act provides that the Minister may by regulations prescribe the amounts of subvention that may be paid. Such amounts may be specified by reference to specified degrees of dependency, means or circumstances of dependent persons or such other matters as the Minister considers appropriate. The rates of subvention were duly fixed by the Nursing Homes (Subvention) Regulations, 1993. To facilitate the operation of the subvention scheme, provisions relating to the administration of the scheme are required. These provisions would cover such areas as making of applications for subvention; onus on applicant to furnish information; assessment of degree of dependency; assessment of means and circumstances; calculation of amounts payable; notification of decision on applicants; review of subventions decision; death or discharge of patient; services to be covered by subvention; appeals against decisions and recoupment of subventions. It is proposed, therefore, to amend section 7(2) to provide the powers to prescribe any necessary administrative and technical details.
In addition, a further amendment of the Act is required to take account of the introduction by the Minister for Finance of a scheme of tax allowances in respect of capital expenditure on private convalescent homes in the Finance Act, 1999. The allowances apply to expenditure incurred on or after 2 December 1998 on the construction, extension or refurbishment of a convalescent home as well as the conversion of an existing building into a convalescent home. To ensure the standard of care in convalescent homes is satisfactory, it is proposed that such homes be required to be registered under the Nursing Homes Act.
Regulations have been made under section 6 of the Act for the purpose of ensuring proper standards in nursing homes. It will be necessary to make similar regulations governing standards in convalescent homes, which may include provisions requiring convalescent homes to have adequate medical, nursing and para-medical staff and facilities consistent with the patient profile of the home. It is proposed, therefore, to amend section 6 of the Act to give ministerial power to prescribe different requirements for such homes.
At this point, I would like to outline the contents of the Bill. Section 1 amends section 59 of the Health Act, 1970 by the substitution of a new section for the existing section. Subsections (1), (2) and (3) provide for the supply of approved, prescribed, drugs, medicines and medical and surgical appliances to people with full eligibility and people with limited eligibility and their dependants. Subsection (4) provides for the supply of approved, prescribed medicines to medical card holders by dispensing doctors and for the supply of non drug items to people with full eligibility and limited eligibility by other persons, as approved by the Minister. Subsection (5) provides for the supply of approved, prescribed drugs by an institution that provides a specialist service under the direct supervision of a medical consultant and stands approved by the Minister. Subsection (6) provides for the making of regulations specifying the terms and conditions upon which, and the extent to which, health boards may defray the cost of supplying a particular drug or drugs, or drugs for the treatment of a particular condition or conditions. Subsection (7) provides for the granting of an approval by the Minister for the purposes of the previous subsections and for the withdrawal of an approval for stated reasons and in accordance with regulations.
Subsection (8) is a standard provision to the effect that the Minister may make regulations for the purposes of this section. Subsection (9) provides that regulations may provide for the manner in which payments may be made in respect of drugs supplied by community pharmacies and persons referred to in subsections (4) and (5) and in respect of fees for services. The regulations may also provide for the furnishing of information required on drugs supplied and services provided and for the refusal of payment if a request for information is not complied with. Subsection (10) provides for regulations on agreements between the proprietor of pharmacies and health boards pursuant to which community pharmacies supply drugs for the purpose of this section. Subsection (11) provides that where a supplier of drugs to community pharmacies fails or refuses to comply with a request under regulations, the supplier shall be guilty of an offence and liable on summary conviction to a fine not exceeding £1,500.